Pupil Dilation for Treatment of IFIS

NCT03760185 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 18-1713
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

A novel intervention for targeting the treatment of Intraoperative Floppy Iris Syndrome.

Conditions

Intraoperative Floppy Iris Syndrome

Outcome Measures

Primary Outcomes (1)

• Pupil Dilation Sized of the Treated Eye Compared to the Non-treated Eye

  The primary outcome measure is pupil diameter size post dilation (using standard dilating medications of phenylephrine 10%, tropicamide 1%, and cyclopentolate 1%) of the brimonidine tartrate pre-treated eye compared to the non-treated eye

  45 minutes post dilation after 7 days of treatment

Secondary Outcomes (1)

• Change in Pupil Diameter of Each Eye After Dilation at the Start of the Study Compared to Pupil Post Dilating Drops at the End of the Study

  45 minutes post dilation after 7 days of treatment

Study Arms (2)

Brimonidine Tartrate 0.2%

EXPERIMENTAL

One eye was treated with Brimonidine Tartrate 0.2% after a 20-day washout period. Patients will treat right eye 3 times per day for 7 days of treatment.

Drug: Brimonidine Tartrate

Control - untreated

NO INTERVENTION

The left eye will serve as the control for the study and will not receive the Brimonidine Tartrate 0.2% treatment

Interventions

Brimonidine Tartrate DRUG

All subjects will apply brimonidine tartrate to one eye (right eye) only for the duration of study participation.

Also known as: "Eye Drops"

Brimonidine Tartrate 0.2%

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Adults (18 years old or greater) 3. History of having taken, or currently taking any systemic alpha blocker 2. Ability to consent themselves 3. Ability to apply eye drops themselves TID for 7 days

You may not qualify if:

• Subjects with untreated hypertension or baseline BP \>160
• Subjects with Thyrotoxicosis
• Pregnant women or women trying to conceive
• Prisoners
• Inability consent
• Subjects with anatomical narrow angles or who have never had a dilated eye exam
• Subjects currently prescribed brimonidine tartrate for glaucoma
• Subjects who take topical or systemic alpha agonists
• Patients who take monoamine oxidase (MAO) inhibitors
• Patients with known severe cardiovascular disease

Sponsors & Collaborators

• Denver Health and Hospital Authority: lead

Study Sites (1)

Denver Health

Denver, Colorado, 80204, United States

Location

MeSH Terms

Interventions

Brimonidine Tartrate; Ophthalmic Solutions

Intervention Hierarchy (Ancestors)

Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Results Point of Contact

• Title: Dr Cristos Ifantides
• Organization: Denver Health and Hospital Authority

Cristos.Ifantides@dhha.org

303-436-4949

Study Officials

• Cristos Ifantides, MD

  Denver Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single arm study in which all enrolled subjects will receive eye drops to only one eye. The alternative eye will serve as the control for efficacy.

Study Record Dates

• First Submitted: November 28, 2018
• First Posted: November 30, 2018
• Study Start: January 4, 2019
• Primary Completion: September 25, 2020
• Study Completion: September 25, 2020
• Last Updated: April 20, 2022
• Results First Posted: April 20, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)